- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07599215
A Novel Interruption Management Intervention for New Graduate Nurses During Medication Administration
A Novel Interruption Management Intervention for New Graduate Nurses During Medication Administration: A Pilot Randomized Trial
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Massachusetts
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Springfield, Massachusetts, Stati Uniti, 01199
- Baystate Medical Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Inclusion Criteria:
- A convenience sample of new graduate nurses within the first year of practice as a nurse.
Exclusion Criteria:
- nurses with >1 year of practice
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Stay S.A.F.E. Interruption Management Education
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The Stay S.A.F.E. strategy is a structured, behavioral approach designed to support task focus and safe task resumption during interruptions. It consists of the following steps: Stay physically in the current location and remain engaged in the primary task; when possible, physically hold task-related items. Say aloud what you are doing at the moment of interruption, being as specific as possible while maintaining patient privacy. Acknowledge the person interrupting you without looking away from the primary task. Fixate visually and cognitively on the current place in the task for one to two seconds and identify a natural stopping point. Estimate the time needed to complete or pause the task before attending to the interrupter, providing a realistic timeframe.
11 slide narrated PowerPoint presentation focused on medication safety practices.
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Comparatore fittizio: Medication Safety Education
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11 slide narrated PowerPoint presentation focused on medication safety practices.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Response to Interrupter Using the Stay S.A.F.E. Strategy
Lasso di tempo: During simulation (immediate assessment at interruption; within a 30 minute session)
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The primary outcome is the participant's response to a clinical interruption, assessed using an eye tracking device (ETD).
Study personnel recorded interruption management behaviors, Stay S.A.F.E., using a structured data collection tool and whether the participant immediately accepted the interruption ("took report").
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During simulation (immediate assessment at interruption; within a 30 minute session)
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Time away from primary task
Lasso di tempo: During simulated interruption event (from onset of interruption to return to primary task; within a 30-minute session)
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Time away from the primary medication-administration task is measured using eye tracking device (ETD) recordings.
Two trained study team members review recorded sessions to determine the duration between the onset of the interruption and the participant's return to the primary task, defined as the point at which the participant's ETD crosshairs re-engage with the medication-administration activity.
Time is calculated using timestamp data captured within the ETD recordings.
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During simulated interruption event (from onset of interruption to return to primary task; within a 30-minute session)
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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medication administration errors
Lasso di tempo: During simulation (real-time assessment with post-simulation validation; up to 30 minutes).
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Medication administration errors are assessed during the simulation using a structured observational checklist. Evaluated components include patient identification (e.g., armband scanning and electronic medical record verification), medication identification, dosage, route, and timing. Each task component is documented as: Yes (correct task completion) No (incorrect task completion) Corrected (initially incorrect but subsequently corrected by the participant) Data are initially recorded on a standardized paper checklist during the simulation. To ensure accuracy and reliability, two study team members perform an independent review of eye tracking device (ETD) recordings to validate observed performance and recorded outcomes. Outcome data may be summarized as proportions of correctly completed tasks, error rates, and frequency of corrected actions. |
During simulation (real-time assessment with post-simulation validation; up to 30 minutes).
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Perceived Workload (NASA Task Load Index)
Lasso di tempo: Immediately following the simulation (within a 30-minute session).
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Perceived workload is assessed using the NASA Task Load Index (NASA-TLX), a validated self-report instrument developed by the NASA Ames Research Center. Participants complete the NASA-TLX electronically on an iPad immediately following the simulation The NASA-TLX consists of six subscales: mental demand, physical demand, temporal demand, performance, effort, and frustration. Each subscale is rated on a 20-point scale, with higher scores indicating greater perceived workload. Both overall workload scores and individual subscale scores are calculated and analyzed to characterize participant workload during the simulation. The NASA-TLX has demonstrated reliability and validity across simulation, laboratory, and applied clinical settings. |
Immediately following the simulation (within a 30-minute session).
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Collaboratori e investigatori
Sponsor
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Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- BaystateMC
- no number provided (Altro numero di sovvenzione/finanziamento: Beta Zeta Chapter of Sigma Theta Tau)
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .